Q&A: Sharp HealthCare’s Commitment to, and Experience With, Clinical Trials

Posted on January 11, 2023January 13, 2023 by Leo Bogee

Five questions for DeAnn Cary, PhD, Director of Research at Sharp HealthCare

Clinical trials are critical to advancing medicine and patient health but participating in them is not easy. Hospitals that serve as clinical trial sites must invest significant time and resources into the process, and one of the most time-consuming elements relates to identifying and enrolling patients in clinical trials.

While many hospitals rely on manual reviews, outdated reports, and other time-consuming methods to find the right candidates, innovative clinical trial sites are turning to new technology that makes the identification and enrollment process much more efficient.

One such organization is Sharp HealthCare, which is using VigiLanz Research to accurately and quickly identify eligible candidates for clinical trial enrollment. In this Q&A, DeAnn Cary, PhD, Director of Research at Sharp HealthCare, discusses the hospital’s approach to clinical trials and why it began using this new technology to support its research efforts.

Tell us about Sharp HealthCare and why it participates in clinical trials?

DC: Sharp HealthCare is a not-for-profit health system based in San Diego that is made up of four acute-care hospitals, three specialty hospitals, three affiliated medical groups, and a full spectrum of other facilities and services.

As a community health system, we firmly believe that it is important to offer cutting edge treatments to our patients. Clinical trials provide opportunities to access the newest treatments (e.g., drugs, devices, or procedures) that would not otherwise be available to them.

How do you choose which clinical trials to participate in and how has your overall participation in trials changed over the past few years?

DC: When reviewing new trials, we consider several things including our existing portfolio (we typically avoid having competing trials). We also consider whether our patient population is a good fit, as well as whether we have the resources and bandwidth required to meet the requirements and timelines.

We have increased our participation and patient volume in some areas, such as Alzheimer’s. We have decreased our patient volume in other therapeutic areas, such as oncology. Study design and precision medicine has dramatically expanded the inclusion/exclusion criteria making it much harder to find patients who qualify. Precision medicine is definitely better for the patients but more challenging for the teams trying to recruit.

What methods have you historically used to recruit patients?

DC: We advertise for some studies, particularly for those which the sponsor pays for all activities associated with the study. In other therapeutic areas, in which insurance is involved (such as oncology), it’s more challenging to advertise because not all potential patients have insurance that the clinics accept. In those instances, the recruitment process is highly manual and primarily consists of chart reviews.

How have you improved your clinical trial processes over the years?

DC: The biggest significant improvement in processes has been the use of VigiLanz Research. VigiLanz Research leverages study-specific inclusion and exclusion criteria to automatically review all patients across a hospital network. It screens the entire patient population to identify eligible patients in real time and provides automated alerts and notifications to key team members when there are eligibility matches.

Key benefits of VigiLanz Research include the real-time patient identification for studies that have a very short timeline for identification and recruitment (e.g., cardiac and stroke).

VigiLanz Research has also enabled our small staff of clinical research coordinators to feel confident that they have not missed a single qualified potential research participant. It has also enabled them to focus their time and energies on the patients who meet or nearly meet the study criteria, rather than having to manually review hundreds of patient charts.

“VigiLanz Research has also enabled our small staff of clinical research coordinators to feel confident that they have not missed a single qualified potential research participant.”
—DeAnn Cary, PhD, Director of Research at Sharp HealthCare

Do you believe VigiLanz Research will make Sharp a better candidate for future clinical trials?

DC: Yes, and we are starting to see some of our sponsor feasibility questionnaires ask if we are using a real-time patient identification platform. As this becomes more common, having a technology like VigiLanz Research will continue to be critical, not only for our success within particular trials, but in our ability to continue participating in trials in general.

Read this case study to learn more about how Sharp is using VigiLanz Research to support clinical trial enrollment.

Related Resources: VigiLanz Research

Sharp Grossmont Hospital Uses VigiLanz for Fast, Accurate Patient Recruitment in Clinical Trials

Posted on November 18, 2022January 13, 2023 by Sage Growth Partners

Customer Profile

Sharp HealthCare, a not-for-profit health system based in San Diego, is made up of four acute-care hospitals, three specialty hospitals, three affiliated medical groups, and a full spectrum of other facilities and services. Sharp Grossmont Hospital, the largest healthcare facility in East San Diego County with 536 beds, is known for outstanding programs in emergency and critical care, cardiac care, orthopedics, rehabilitation, neurology, women’s health, children’s health and hospice care.

Challenge

Sharp Grossmont Hospital is dedicated to expanding scientific knowledge and supporting medical advancements by serving as a clinical trial site. However, recruiting and enrolling patients in clinical trials is a challenging, labor-intensive, and time-consuming process. Industry research suggests that 11% of clinical trials never enroll a patient and 68% of sites fail to meet enrollment targets. When Sharp Grossmont Hospital began participating in a complex clinical trial in early 2020, it quickly became apparent that they were going to face similar challenges.

The trial was designed to evaluate the safety and efficacy of a new drug to reduce the risk of major cardiovascular events in patients with acute coronary syndrome and had a complex protocol that made clinical trial enrollment extremely difficult. Sharp Grossmont Hospital’s clinical research team, who at the time relied on a manual review process to identify eligible patients, found that the workflow was extremely inefficient.

“Screening for clinical trials with extensive and specific inclusion and exclusion criteria is very time-consuming,” said DeAnn Cary, PhD, Director of Research at Sharp HealthCare. “Manually screening for a trial like ours means casting a wide net to find potential subjects since they can be in multiple areas of the hospital.”

Solution

Sharp Grossmont Hospital knew there had to be a better way to approach clinical trial enrollment, and in 2020, partnered with VigiLanz to explore an alternative model. VigiLanz Research facilitates a more efficient recruitment process by continuously reviewing EHR data to find patients for clinical trials in real time.

Kyra Rashid, BS, MCR, Clinical Trial Specialist at Sharp, said the solution helps the organization identify eligible patients more quickly, including patients who might have otherwise been missed.

“The technology alerts our team as soon as eligible patients are identified, based on the study-specific inclusion and exclusion criteria,” she said. “It screens the entire hospital patient population, which saves us a significant amount of time that can then be reallocated to other initiatives.”

In addition to screening patients for the clinical trial, the solution provides:

A dynamic worklist that coordinators can use to view or modify patient eligibility status in real time
Automatic alerts that notify coordinators anytime an eligible candidate is located within the hospital network
Enterprise-level reporting that coordinators and leaders can use to evaluate study performance and easily evaluate potential clinical trials.

How VigiLanz Research Works

VigiLanz leverages study-specific inclusion and exclusion criteria to automatically review all patients across a hospital network.
VigiLanz screens the entire patient population to identify eligible patients in real time.
VigiLanz provides automated alerts and notifications to key team members when it identifies eligible patients.
Coordinators can track eligibility status, run timely reports, and manage the recruitment process in a customized worklist.

Outcomes

As a result of the VigiLanz Research partnership, Sharp Grossmont Hospital reduced the time needed to screen and enroll patients in the clinical trial. The time savings and workflow improvements also positively benefited the clinical research team.

“The coordinators’ time is now focused on a more narrowed pool of potential subjects, which allows more time to continue additional screening and accomplish more tasks in our day,” said Cary E. Murphy, BSN, CCRC, Clinical Trial Specialist at Sharp Healthcare. “This makes the team happier and more productive.”

Overall, the partnership:

Increased the number of patients screened. VigiLanz Research increased the number of patients screened to include all ED patients and all patients admitted in all 20 hospital departments.
Cut the time spent screening patients in half. The technology solution reduced the time needed to screen patients, freeing up the clinical research team to work on other high-value tasks.
Identified eligible patients faster. VigiLanz Research helped the team identify eligible patients in real time, which was vital to this time-sensitive study.

Another key benefit, Cary said, is the positive impact the new approach brings patients. “VigiLanz Research has improved our team’s efficiency and helped us ensure more eligible patients can participate in the trial. VigiLanz also helps ensure no potential study participant, regardless of department, is missed. As we work to advance drug and treatment development, we’re excited about how this approach will support those efforts.”

To learn more about how VigiLanz helps hospitals with efficient patient recruitment for clinical trials, visit https://vigilanzcorp.com/ today.

Related Resources: VigiLanz Research

VigiLanz Announces Launch of New Clinical Trial Patient Identification Solution

Posted on October 11, 2022February 8, 2023 by Sage Growth Partners

VigiLanz Research will help hospitals and clinical research staff increase the number of patients identified for clinical trials, while reducing time and staff effort needed for manual screening

MINNEAPOLIS – October 11, 2022 – VigiLanz, a clinical software surveillance company, has announced the launch of a new solution that will empower researchers to accurately identify more eligible candidates for clinical trial enrollment in near real time. By automating the patient identification process, VigiLanz Research will provide help for clinical trial sites seeking to accelerate patient recruitment, meet time-sensitive enrollment targets, and gain insights on patients screened for eligibility.

Clinical trial screening is often an inefficient, costly, and labor-intensive process for clinical trial sites. More than half of all clinical trials fail to meet their enrollment targets, and nearly a quarter close because of insufficient patient enrollment.

“VigiLanz Research is streamlining the clinical trial recruitment process,” said Dr. David Goldsteen, Chief Executive Officer at VigiLanz, noting that for years clinical research sites have struggled to enroll enough patients. “This new solution leverages our two decades of clinical surveillance expertise into a system that empowers researchers to screen more qualified candidates. For hospitals, this increases the likelihood for clinical trial success, and for sponsors, this potentially saves millions of dollars and helps get products to market faster. Most importantly, it also connects people with opportunities for life-changing treatments that could help them live longer, healthier lives.”

VigiLanz recently partnered with Sharp HealthCare to implement VigiLanz Research for an acute cardiac clinical trial, which has a complex protocol and challenging patient enrollment requirements. VigiLanz Research automated screening processes using data in Sharp’s electronic health record (EHR), vastly increasing the number of patients screened to include all patients in all units, and reducing staff time needed to screen patients by 50%. This not only led to more patients being successfully enrolled in the study, but also improved staff satisfaction by giving them more time to focus on other high-value tasks.

“VigiLanz Research has not only improved our team’s efficiency but also has helped us make a difference in patients’ lives. This solution solved the biggest challenges we had in screening patients for this study – the short enrollment windows. With near real-time updates, we can now identify and enroll subjects who may have otherwise been missed,” said DeAnn Cary, PhD, Director of Research at the Outcomes Research Institute at Sharp HealthCare.

Sharp HealthCare and VigiLanz will be presenting an overview of the research process and the results at the WCG MAGI West 2022 conference in Las Vegas in mid-October. To learn more about VigiLanz Research, visit vigilanzcorp.com/research.

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About VigiLanz
Founded in 2001, VigiLanz is a privately held, rapidly growing provider of SaaS-based clinical surveillance, safety, quality, and risk solutions. The organization is focused on transforming the delivery of quality care by aggregating disparate EHR transactional workflow and documentation data across health systems to identify real-time clinical issues that avoid or minimize harm, optimize clinical outcomes, and support preventive care. VigiLanz is a clinical partner to a large and growing community of hospital CMOs, CMIOs, CIOs, quality and safety teams, infectious disease and control specialists, pharmacists, and other clinicians dedicated to innovative, real-time inpatient care.

For More Information
John Gonda
(616)-309-4888
jgonda@sage-growth.com